Pharmaceutical Firm Rejects Fda Drug Recall

June 14, 1991|By Steven Morris.

Pharmaceutical Basics Inc., a Chicago-based firm with plants in Denver and Morton Grove, has refused a Food and Drug Administration request to recall 62 generic drugs that the agency says gained approval through fraud.

Pharmaceutical Basics said the recall request was based on bureaucratic nitpicking, not on evidence that the drugs are ineffective or dangerous.

Involved are drugs tested and made at the Denver plant, which the firm bought in 1986.

The company`s reviews of test records of the former owner disclosed discrepancies, of which Pharmaceutical Basics informed the FDA. The recall request arises from those discrepancies.

Included on the FDA`s list of drugs for re-call are baclofen, a muscle relaxant; clorazepate dipotassium, an anxiety medication; desipramine hydrochloride, an antidepressant; fenoprofen calcium, an arthritis medication; and lithium carbamate, a treatment for manic-depressive illness. The FDA is not requesting that other companies that produce the drugs re-call their products.

Dr. Elio Mariani, vice president of Pharmaceutical Basics, refused to comment on the matter Thursday. The FDA has referred the matter to its Denver office.

``We`re still in negotiations to determine what the next step is,`` said Faye Peterson, an FDA spokeswoman in Washington.

In a May 1 letter to Pharmaceutical Basics, Ronald G. Chesemore, associate commissioner for regulatory affairs, said the FDA intended to downgrade the codes that indicate the degree to which the questioned generic drugs match the characteristics of the original, patented versions.

The action is contemplated, he said in the letter, because of ``untrue statements, discrepancies and omissions concerning the manufacturing and control of batches used to support approval applications.``

The agency defines this class as involving situations in which ``the use of or exposure to a violatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.``

On June 6, Piet Bleyendaal, Pharmaceutical Basics` president, responded that comparisons of data on the drugs submitted before and after they were approved and distributed ``indicate that batches produced for commercial distribution generally conform in all pertinent respects`` with the patented versions, including their formulation, raw material content, stability and rates of dissolving.

``We fully acknowledge the agency`s concern that applications fully and accurately report the data on which approvals are sought and ultimately granted,`` he wrote. ``For that reason, we suspended and will continue to suspend distribution of new drugs from the Denver facility until further notice.``